US20150250681A1 - Vial adapter for use with syringe having widened distal syringe tip - Google Patents

Vial adapter for use with syringe having widened distal syringe tip Download PDF

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Publication number
US20150250681A1
US20150250681A1 US14/366,306 US201214366306A US2015250681A1 US 20150250681 A1 US20150250681 A1 US 20150250681A1 US 201214366306 A US201214366306 A US 201214366306A US 2015250681 A1 US2015250681 A1 US 2015250681A1
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US
United States
Prior art keywords
syringe
vial
port
tip
syringe port
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US14/366,306
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English (en)
Inventor
Nimrod Lev
Moshe Gilboa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medimop Medical Projects Ltd
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Medimop Medical Projects Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medimop Medical Projects Ltd filed Critical Medimop Medical Projects Ltd
Assigned to MEDIMOP MEDICAL PROJECTS LTD. reassignment MEDIMOP MEDICAL PROJECTS LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GILBOA, MOSHE, LEV, NIMROD
Publication of US20150250681A1 publication Critical patent/US20150250681A1/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means

Definitions

  • the invention pertains to liquid drug delivery devices for use with syringes having widened distal syringe tips for preventing a conventional needle with a female Luer connector being slidingly mounted thereon.
  • FIGS. 8 to 11 discloses in FIGS. 8 to 11 a liquid drug transfer device including a vial adapter with elastomer tubing for preparing a syringe having a widened distal syringe tip with a reconstituted liquid drug for immediate administration to a subject.
  • the widened distal syringe tip is dimensioned to prevent a conventional needle being slidingly mounted thereon.
  • the elastomer tubing's free end is intended to be sealingly stretched over a syringe's widened distal syringe tip for effecting fluid communication between a syringe and a medical vial containing a medicament requiring reconstitution.
  • Reconstitution typically requires agitation of the assemblage of the liquid drug transfer device, a vial and a syringe which may lead to inadvertent syringe detachment and contents spillage.
  • liquid drug delivery devices including a housing with a syringe port for sealingly receiving a syringe having a syringe tip ending at a widened distal syringe tip, a vial adapter port with a vial adapter for snap fit receiving a vial, and a drug administration port for administering a liquid drug.
  • the vial adapter is intended to be rotationally detached after a mixing procedure for discarding together with a spent vial.
  • the syringe port additionally includes a single use locking mechanism for securing the syringe to preclude inadvertent syringe detachment under normal use including agitation for reconstitution purposes.
  • the drug administration port has a distal syringe tip preferably similar to a syringe's widened distal syringe tip for the same purpose of preventing conventional needles with a female Luer connector being slidingly mounted thereon.
  • the present invention is directed toward vial adapters for safely and securely preparing a syringe having a widened distal syringe tip with a liquid drug for immediate administration to a subject.
  • the vial adapters include a skirt for snap fitting onto a drug vial, a puncturing spike for puncturing a drug vial stopper and a syringe port in fluid communication with the puncturing spike and designed to snap fit onto a widened distal syringe tip.
  • the syringe port preferably includes two or more upright syringe port members designed to initially outwardly flex on initial sliding insertion of the widened distal syringe tip thereinto and subsequently snap behind the widened distal syringe tip on its forced full sliding insertion thereinto to retain the widened distal syringe tip in the syringe port.
  • the syringe port is also designed to enable convenient detachment of a filled syringe from an assemblage of a vial adapter and its emptied vial by manual application of a detachment force to momentarily outwardly flex one or more of its syringe port members.
  • the syringe port is also designed such that inadvertent insertion of a syringe with a conventional Luer tip will neither form a sealed flow communication therewith nor mechanically engage the syringe port.
  • the vial adapter of the present invention enables secure reconstitution of a drug medicament without concern of inadvertent detachment.
  • the vial adapter is designed for convenient low cost manufacturing.
  • the vial adapters of the present invention can be implemented in vented or non-vented versions.
  • FIG. 1A corresponds to aforesaid commonly owned WO 2005/105014's FIG. 8 showing a liquid drug transfer device including a vial adapter with elastomer tubing for preparing a syringe having a widened distal syringe tip with a reconstituted liquid drug for immediate administration to a subject;
  • FIG. 1B corresponds to aforesaid commonly owned WO 2005/105014's FIG. 9 showing a longitudinal cross section of the liquid drug transfer device along line A-A in FIG. 1A ;
  • FIG. 2A corresponds to aforesaid commonly owned WO 2009/040804's FIG. 6 showing a liquid drug delivery device including a syringe port with elastomer tubing and an automatic single use locking mechanism for use with a syringe having a widened distal syringe tip for safely and securely preparing the syringe with a reconstituted liquid drug;
  • FIG. 2B corresponds to aforesaid commonly owned WO 2009/040804's FIG. 8 showing an assembled side view of the liquid drug delivery device and a syringe with a widened distal syringe tip;
  • FIG. 3 is a top perspective view of a vial adapter with a syringe port for use with a syringe with a widened distal syringe tip in accordance with the present invention
  • FIG. 4 is a longitudinal cross section of FIG. 3 's vial adapter along line B-B in FIG. 3 ;
  • FIG. 5 is longitudinal cross section of FIG. 3 's vial adapter along line B-B in FIG. 3 subsequent to partial insertion of the widened distal syringe tip into the syringe port;
  • FIG. 6 is longitudinal cross section of FIG. 3 's vial adapter along line B-B in FIG. 3 subsequent to full snap fit insertion of the widened distal syringe tip into the syringe port;
  • FIGS. 7A to 7D show the use of the vial adapter of the present invention for preparing a syringe with a reconstituted liquid drug ready for administration.
  • FIG. 1A shows a syringe 10 , a vial 16 and a liquid drug transfer device 20 for liquid drug reconstitution purposes.
  • the syringe 10 includes a barrel 11 with a plunger 12 and a syringe tip 13 ending at a widened distal syringe tip 14 for preventing the sliding mounting of a conventional needle with a female Luer connector thereon.
  • the syringe tip 14 has an outer diameter D 1 , a length L 1 and an annular trailing surface 15 .
  • the syringe 10 includes liquid contents for forming a liquid drug in the vial 16 .
  • the liquid contents can be constituted by a diluent for reconstituting a powder drug or mixing with a liquid drug.
  • the liquid contents can include an active drug component.
  • the vial 16 includes an open topped bottle 17 A, a vial opening 17 B stopped by a drug vial stopper 18 , and a narrow neck 17 C intermediate the bottle 17 A and the vial opening 17 B.
  • the bottle 17 A has a vial interior 19 including a powder or liquid drug 19 .
  • FIGS. 1A and 1B show the liquid drug transfer device 20 includes a vial adapter 21 with a top wall 22 , a resiliently deformable slitted skirt 23 for snap fitting onto the vial 16 , and a hollow puncturing spike 24 for puncturing the vial stopper 18 , and an elastomer tubing 26 in flow communication with the puncturing spike 24 .
  • the tubing 26 has a distal end 27 for sealingly fitting over the syringe tip 14 for enabling flow communication between the syringe 10 and the vial 16 .
  • the tubing 26 has an internal diameter D 2 where D 2 ⁇ D 1 and a free length L 2 from its attachment point with the vial adapter 21 where L 2 >L 1 for being sealingly stretched over preferably the entire syringe tip 14 without tearing, ripping, and the like.
  • the tubing 26 is preferably formed from one of the following substances: PVC, silicone, rubber, and the like.
  • FIGS. 2A and 2B show a liquid drug delivery device 70 A for use with a syringe 10 and a vial 16 .
  • the liquid drug delivery device 70 A is similar in construction and operation to the fluid control device illustrated and described in U.S. Pat. No. 6,238,372 to Zinger et al.
  • the fluid control device 70 A includes a syringe port 71 designed to effect sealed fluid communication with a syringe 10 and a drug administration port 72 having a widened distal syringe tip 73 for preventing conventional needles with a female Luer connector being slidingly mounted thereon in a similar manner as the syringe 10 .
  • the syringe port 71 includes an inlet port 74 provisioned with an elastomeric tubular sealing member 76 constituted by elastomer tubing 77 having a free end 78 and co-axial with a longitudinal axis 32 .
  • the tubing 77 is preferably formed from PVC, silicon, rubber, and the like, for sealingly receiving the syringe tip 14 on forced sliding insertion thereinto.
  • the inlet port 74 supports an automatic single use locking mechanism 79 for precluding inadvertent syringe detachment.
  • the locking mechanism 79 includes a solid tubular guide member 81 co-axial with the longitudinal axis 32 for assisting in user alignment of the syringe 10 along the longitudinal axis 32 for insertion into the syringe port 71 but with an inner diameter D 4 slightly larger than D 1 such that the syringe tip 14 can freely pass therethrough.
  • the guide member 81 has four equispaced resiliently flexible stopping members 82 inwardly converging towards a vial adapter port 36 and terminating at stopping member tips 82 A which stop short of the free end 78 by a separation S 1 and define an aperture having a smaller diameter than the diameter D 1 such that the syringe tip 14 resiliently radially outwardly urges the stopping members 82 which snap behind same to encircle the syringe tip 14 on forced sliding insertion therethrough. Inadvertent detachment of the syringe 10 from the liquid drug delivery device 70 A is prevented by the trailing surface 15 stopping against the stopping member tips 82 A.
  • the separation S 1 is smaller than the length L 1 for ensuring the syringe tip 14 remains within the tubing 77 when the trailing surface 15 abuts against the stopping member tips 82 A in the most rearward position of the syringe 10 with respect to the device 70 A.
  • FIGS. 3 to 6 show a vial adapter 100 having a longitudinal vial axis 101 and including a transverse top wall 102 having a downward depending skirt 103 with flex members 104 for snap fitting onto a vial 16 .
  • the vial adapter 100 includes a downward depending hollow puncturing spike 106 for puncturing the drug vial stopper 18 on snap fitting the skirt 103 on the vial 16 for flow communication with the vial interior 19 , and a central axial directed syringe port 107 oppositely directed to the puncturing spike 106 and in flow communication therewith.
  • the syringe port 107 includes an annular base 108 and a pair of upright opposite syringe port members 109 resiliently flexibly mounted thereon.
  • the syringe port members 109 each have inwardly directed syringe port member rim 111 .
  • the syringe port member rims 111 each have an uppermost inclined surface 112 A facing away from the base 108 and converging theretowards, an underside syringe port member rim surface 112 B facing towards the base 108 , and an intermediate axial directed syringe port member rim surface 112 C between its adjacent uppermost inclined surface 112 A and the underside syringe port member rim surface 112 B.
  • the syringe port member rim surfaces 112 C define an opening 113 with a diameter D 5 where D 5 ⁇ D 1 such that initial sliding insertion of a syringe tip 14 into the syringe port 107 outwardly flexes the syringe port members 109 relative to the longitudinal vial axis 101 as denoted by arrows A in FIG. 5 .
  • the syringe port members 109 snap behind the widened distal syringe tip 14 on its forced full insertion into the syringe port 107 such that their underside syringe port member rim surfaces 112 B stop against the syringe tip's annular trailing surface 15 to retain the widened distal syringe tip 14 in the syringe port 107 (see FIG. 6 ).
  • the syringe port members 109 preferably revert to their unflexed position.
  • the annular base 108 is fitted with an O-ring like sealing member 114 formed from suitable bio-compatible materials, for example, rubber, silicon, and the like.
  • the sealing member 114 has an uppermost surface 114 A facing towards the underside syringe port member rim surfaces 112 B.
  • the sealing member's uppermost surface 114 A and the underside syringe port member rim surfaces 112 B define a length L 3 where L 3 ⁇ L 1 such that the syringe tip 14 compresses the sealing member 114 on full sliding insertion of the syringe tip 14 into the syringe port 107 (see FIG. 6 ).
  • FIGS. 7A to 7D show the use of the vial adapter 100 as follows:
  • FIG. 7A shows an assemblage 120 of a vial adapter 100 and a vial 16 after snap fitting mounting the former onto the latter.
  • the assemblage 120 has a longitudinal assemblage axis 121 co-axial with the longitudinal axes of the vial adapter and the vial.
  • FIG. 7B shows the assemblage subsequent to full snap fit insertion of the syringe 10 into the syringe port 107 to ensure a sealed flow connection and injection of the syringe's liquid contents into the vial for reconstitution purposes as denoted by arrow B.
  • FIG. 7C shows the assemblage and the syringe subsequent to inversion for aspiration of the reconstituted liquid drug into the syringe 10 for aspiration purposes as denoted by arrow C.
  • FIG. 7D shows application of a detachment force D skewed relative to the longitudinal assemblage axis 121 to enable detachment of the syringe from the vial adapter 100 and its empty attached vial

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
US14/366,306 2011-12-19 2012-12-09 Vial adapter for use with syringe having widened distal syringe tip Abandoned US20150250681A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IL217091A IL217091A0 (en) 2011-12-19 2011-12-19 Vial adapter for use with syringe having widened distal syringe tip
IL217091 2011-12-19
PCT/IL2012/050516 WO2013093908A1 (en) 2011-12-19 2012-12-09 Vial adapter for use with syringe having widened distal syringe tip

Publications (1)

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US20150250681A1 true US20150250681A1 (en) 2015-09-10

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US14/366,306 Abandoned US20150250681A1 (en) 2011-12-19 2012-12-09 Vial adapter for use with syringe having widened distal syringe tip

Country Status (8)

Country Link
US (1) US20150250681A1 (cs)
EP (1) EP2771047A1 (cs)
JP (1) JP5671661B2 (cs)
CN (1) CN104185487A (cs)
BR (1) BR112014014483A2 (cs)
IL (2) IL217091A0 (cs)
IN (1) IN2014DN05899A (cs)
WO (1) WO2013093908A1 (cs)

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US11007119B2 (en) 2009-07-29 2021-05-18 Icu Medical, Inc. Fluid transfer devices and methods of use
US9827163B2 (en) 2009-07-29 2017-11-28 Icu Medical, Inc. Fluid transfer devices and methods of use
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US12350237B2 (en) 2011-08-18 2025-07-08 Icu Medical, Inc. Pressure-regulating vial adaptors
US9895291B2 (en) 2011-08-18 2018-02-20 Icu Medical, Inc. Pressure-regulating vial adaptors
US9883987B2 (en) 2011-12-22 2018-02-06 Icu Medical, Inc. Fluid transfer devices and methods of use
US11439570B2 (en) 2011-12-22 2022-09-13 Icu Medical, Inc. Fluid transfer devices and methods of use
US10314764B2 (en) 2011-12-22 2019-06-11 Icu Medical, Inc. Fluid transfer devices and methods of use
US12023304B2 (en) 2011-12-22 2024-07-02 Icu Medical, Inc. Fluid transfer devices and methods of use
US11439571B2 (en) 2011-12-22 2022-09-13 Icu Medical, Inc. Fluid transfer devices and methods of use
US9987195B2 (en) 2012-01-13 2018-06-05 Icu Medical, Inc. Pressure-regulating vial adaptors and methods
US10299989B2 (en) 2012-03-22 2019-05-28 Icu Medical, Inc. Pressure-regulating vial adaptors
US11654086B2 (en) 2012-03-22 2023-05-23 Icu Medical, Inc. Pressure-regulating vial adaptors
US12280013B2 (en) 2012-03-22 2025-04-22 Icu Medical, Inc. Pressure-regulating vial adaptors
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JP2015504716A (ja) 2015-02-16
CN104185487A (zh) 2014-12-03
IN2014DN05899A (cs) 2015-06-05
IL232820A0 (en) 2014-07-31
WO2013093908A1 (en) 2013-06-27
JP5671661B2 (ja) 2015-02-18
EP2771047A1 (en) 2014-09-03
IL217091A0 (en) 2012-02-29

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